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CompletedNCT06057493Updated Feb 29, 2024

RDP Reliability Study

An observational study in Healthy, sponsored by Optina Diagnostics Inc.. Completed at 1 site in Canada. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-29.

Sponsored by Optina Diagnostics Inc. · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
43
Ages
50 Years and older
Sex
All
01

Study summary

This is an observational study designed to assess the reliability and consistency of the Optina awAIrTM CAS Test for detecting phenotypic changes in the retina that are associated with beta-amyloid status (positive or negative). The purpose of this study is to ensure that the retinal image capture process is consistent and under control, regardless of the operator or the time of measurement. The study will include enough repeated measurements on different systems, by three operators, and at different times to demonstrate.

Read the detailed description

The purpose of this study is to assess the reliability of the Optina Retinal Deep Phenotyping.TM(RDP) platform. The RDP Platform is comprised of the Optina-4CTM retinal camera and its Optina-4C ConnectTM software, as well as the Optina awAIrTM-CAS Test (also called CAS Test) for detecting phenotypic changes in the retina that are associated with cerebral beta-amyloid status (positive or negative). This study will quantify points of variability in the data input for the CAS Test, including:

  • Left eye vs. right eye (retinal scan)
  • Eye algorithm selection (eye assessment obtained from different eye specialists either an Ophthalmologist or an Optometrist)
  • Hardware variability (Inter-instrument Variability retinal scans obtained from different Optina-4CTM cameras)
  • Inter-operator variability (retinal scans obtained from different Users of the Optina-4CTM camera)
  • Intra-operator variability (retinal scans obtained by the same user on the same Optina-4CTM camera
02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Optina Diagnostics Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Men and women 50 years and older who can undergo pupil dilation for both eyes and are not contraindicated for mydriatic imaging with a fundus camera.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male and female adults aged 50 years and older with vision in both eyes.
  • Sufficient fluency in English or French to participate in study visits.
  • Ability to give .
  • Individuals with both eyes meet the eligibility criteria for retinal imaging.

Exclusion criteria

Exclusion Criteria:

  • Pupil dilation (due to pathology, or presence of 3 quadrants with Van Herick grading of 0 or 1 without iridotomy).
  • Inadequate pupil dilatation (\< 6mm diameter) preventing uniform illumination of the retina with the Optina 4CTM camera.
  • Diagnosis of glaucoma or signs of glaucoma (excavation ratio ≥0.7).
  • Signs of vascular occlusion or retinopathy (microaneurysm, exudate, hemorrhage, or edema) within a diameter of 10 mm from the mid-point between the optic nerve head and the macula.

  • Presence of drusen and/or age-related macular degeneration (AREDS 9-step scale

    ≥4 - cumulative drusen area diameter ≥ 250 µm, pigmentary changes and cumulative drusen area diameter ≥ 63 µm or pigmentary changes and cumulative geographic atrophy area diameter ≥ 354 µm).

  • Nuclear sclerosis > 2 (LOCS II four-point grading system) or presence of central cortical or central posterior subcapsular cataract.
  • Deficient visual fixation (inability to fixate for at least 2 s).
  • Refractive error outside the range of -15 D to +15 D.
  • Corneal or media opacities (e.g., Weiss ring) affecting retinal imaging on a cumulative area > 1 disc area within a diameter of 10 mm from the mid-point between the optic nerve head and the macula (i.e., the area of interest for the Optina 4CTM imaging)
  • Scar, atrophy, naevus, tumor, epiretinal membrane or retinal pucker with a cumulative area > 1 disc area within a diameter of 10 mm from the mid-point between the optic nerve head and the macula.
  • Papilledema and/or optic disc swelling.
  • Macular anomaly (e.g., macular hole, dystrophy, degeneration).
  • Inability to obtain up to 5 images or a minimum of 3 images of satisfactory quality with the Optina 4CTM per the Optina Diagnostics quality index software and /or per the eye specialists' evaluation. This exclusion criterion also applies if participants are unable to provide the required number of images during the second visit as well.
  • Currently taking or has previously taken cerebral amyloid modifying medication.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
43 participants (actual)
Patient registry
No

Interventions

  • OtherRetinal Imaging with Optina4C Camera

    The study consists of 2 visits and 8 Imaging sessions: The participant will go through four (8) imaging sessions in two visits with the Optina-4CTM cameras to get pictures of your retina. These imaging sessions will be done by three qualified operators who have been trained on the study device by Optina Diagnostics.

06

What researchers measure

Primary outcomes

  1. The reliability of the investigational device's imaging process will be analyzed using agreement of CAS Test results within 95% confidence intervals for the following conditions:

    * Eye to eye variability * Eye selection process variability * Instrument to instrument variability * Inter-Operator variability * Intra-Operator variability

    Time frame: 12 months

07

Study locations

1 site
  • LMC Montreal Ville St Laurent
    Montréal, Quebec H4T 1Z9, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2023 to primary completion in Feb 2024, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2023
First posted
Sep 28, 2023
StartActual
Sep 19, 2023
Primary completionActual
Feb 6, 2024
CompletionActual
Feb 6, 2024
Last update
Feb 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06057493
Lead sponsor
Optina Diagnostics Inc.
Responsible party
Sponsor
First posted
Sep 28, 2023
Start date
Sep 19, 2023
Primary completion
Feb 6, 2024
Completion
Feb 6, 2024
Last update
Feb 29, 2024

Study contacts

Ramina Nissan, O.D
principal investigator · LMC Montreal Ville

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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Optina Diagnostics Inc.

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